Job Description

Job Overview:

The IPQA is responsible for ensuring the quality of materials, in-process components, and finished products meet the company’s established quality standards and regulatory requirements. This role plays a key part in the quality assurance in process, ensuring compliance with Good Manufacturing Practices (GMP) and all applicable FDA regulations. The IPQA collaborates with the production team to identify and resolve any quality issues, performs detailed inspections, and maintains accurate records to ensure consistency and compliance across the production line.

General Description - Duties

Work Order Coordination:

• Collaborate with the production department to collect and review work orders, ensuring that all necessary materials and documentation are available before the start of production.

Material Verification & Line Clearance:

• Verify that all materials conform to the work order specifications. If discrepancies arise, coordinate with the supervisor to resolve material mismatches. Follow line clearance procedures to ensure a clean and prepared production environment, preventing cross-contamination.

DHR Management & Compliance:

• Ensure that all steps are followed accurately and in compliance with GMP. Review completed DHRs for accuracy and completeness.

In Process Inspection and Quality Control:

• Collect samples according to the sampling procedure, inspect and send them to the laboratory for further testing as applicable.
• Verify the finished product and release the pallet.
• Collect retain samples according to the current procedure.
• Conduct thorough inspections of first article, in-process & finished products, and packaging to verify they meet defined quality standards and specifications. Make acceptance or rejection decisions based on established criteria.

Compliance:

• Record and report any non-compliance observed in the production line to the IPQA lead and recommend corrective actions, as necessary.

Record Keeping & Reporting :

• Accurately document all observations, inspection results, and non-conformances and notify the supervisor.

Packaging & Labeling Verification:

• Ensure that all packaging and labelling of in-process and finished goods (case and pallet labels) are correct and meet regulatory and company standards before releasing them to the next stage.

Safety & Regulatory Compliance:

• Perform all work under internal safety protocols, GMP, and FDA regulations, ensuring the manufacturing environment meets the highest compliance standards.

Other duties as assigned.

QUALIFICATION requirements (EXPERIENCE, TRAINING, SKILLS, EDUCATION)

Education:

• High School diploma (GED) required. An associate’s degree in a related field is preferred.

Experience:

• 1-3 years of experience in quality control, inspection, or a related role within a regulated industry (pharmaceutical, medical device, or food production) is preferred.

Skills & Abilities:

• Bilingual is preferred.
• Excellent attention to detail with strong observational skills.
• Basic proficiency in Microsoft Office Suite (Excel, Word).
• Good mathematical skills for basic calculations.
• Strong organizational and multitasking abilities, with a commitment to meeting quality standards.

Problem-Solving:

• Ability to quickly identify and resolve quality-related issues, working collaboratively with the production department.

Work Ethic:

• Strong work ethic with a commitment to producing high-quality products while maintaining compliance with all relevant regulations and standards.

Benefits

• Medical, Dental, and Vision
• 401k
• Holiday and Sick pay
• Vacation Pay

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